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510(k) K990284

BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE by Baylis Medical Co., Inc. — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2001
Date Received
January 29, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Septostomy
Device Class
Class II
Regulation Number
870.5175
Review Panel
CV
Submission Type

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